On 16 September 2026, the MDSAP website published a notice that on 13 September 2026 the MDSAP Regulatory Authority Council (RAC) had unanimously agreed to accept the Tanzania Medicines & Medical Devices Authority (TMDA) as an MDSAP Affiliate Member.
Source: MDSAP — Tanzania Medicines & Medical Devices Authority joins MDSAP | mdsap.global/news/tanzania-medicines-medical-devices-authority-joins-mdsap
1. What MDSAP Is
MDSAP — the Medical Device Single Audit Program — is a single audit programme for medical devices. It is built on ISO 13485 “Medical devices — Quality management systems — Requirements for regulatory purposes”, while incorporating the specific regulatory requirements of the participating authorities (the United States FDA, Australia TGA, Brazil ANVISA, Canada Health Canada, and Japan MHLW / PMDA).
On completion of an MDSAP audit, where any nonconformities identified during the audit have been remedied as required and the Auditing Organisation (AO) has confirmed conformity with certification requirements, the AO may issue an MDSAP certificate to the manufacturer.
One of the core objectives of MDSAP is to reduce duplicated regulatory work through regulatory cooperation and the use of audit results, while maintaining the level of quality system oversight for medical devices.
Sources: mdsap.global/about/what-mdsap | mdsap.global/about/benefits-and-use
2. What TMDA Joining MDSAP as an Affiliate Member Means
An Affiliate Member is a regulatory authority that participates in MDSAP and uses MDSAP audit reports and MDSAP certificates to assess the applicable medical device regulatory requirements within its own regulatory framework, including conformity with the manufacturer’s quality management system (QMS).
TMDA has therefore formally entered the MDSAP regulatory cooperation arrangement, and is able to utilise MDSAP audit results within Tanzania’s own regulatory framework.
3. TMDA Already Accepts MDSAP Audit Reports for Quality Audit
Under the current TMDA requirements for quality audit of medical device and in vitro diagnostic manufacturing sites, manufacturers must demonstrate that their products are manufactured in compliance with the current requirements of the ISO 13485 quality management system.
TMDA further states that Class C and Class D medical device and IVD manufacturing sites must in principle complete a quality audit and obtain approval; for manufacturing sites that meet the conditions, TMDA may substitute a Desk Review (documentary review) for a Physical Inspection.
Source: TMDA — Quality Audit | tmda.go.tz/index.php/pages/quality-audit-1
Under the TMDA “Guidelines on Submission of Documentation for Quality Audit of Medical Devices and Diagnostics Manufacturing Sites”, where a manufacturing site is being considered for a Desk Review, the applicant must submit a set of supplementary evidence. This expressly includes audit reports issued within the last three years by an SRA, a Notified Body, MDSAP, another regional harmonisation initiative, or a WHO prequalification programme.
MDSAP audit reports are therefore already listed by TMDA as one of the quality system audit evidence that may be submitted for a Desk Review.
Source: TMDA — Guidelines on Submission of Documentation for Quality Audit of Medical Devices and Diagnostics Manufacturing Sites | tmda.go.tz/uploads/publications/en1755007238-en1706017538-GUIDELINES%20ON%20SUBMISSION%20OF%20DOCUMENTATION%20FOR%20QUALITY%20AUDIT%20OF%20MEDICAL%20DEVICES%20AND%20DIAGNOSTICS%20MANUFACTURING%20SITES.pdf
3.1 Documentary Evidence Required Where Desk Review Is Considered
Where desk review is considered, the applicant is required to submit the following additional documents in order to facilitate a thorough and detailed assessment of the status of the manufacturing site. This is the checklist set out in the TMDA guidance.
| Ref. | Documentary Evidence Required |
| 7.2.2.1 | Certified copy of the appropriate certificate of compliance to ISO 13485 issued by a Stringent Regulatory Authority (SRA) / Notified Body / WHO, together with a certified translation if not in English. |
| 7.2.2.2 | A copy of a valid manufacturing licence issued by the national regulatory authority. |
| 7.2.2.3 | List of all regulatory authorities that carried out an onsite quality audit in the last three years. |
| 7.2.2.4 | Notarised copy of audit report(s) from the SRA, Notified Body, MDSAP, any other regional harmonisation initiative, and/or a WHO prequalification programme carried out within the past three years. |
| 7.2.2.5 | Annual product quality review reports. For single use devices, ideally a report for 25 batches manufactured in the last 36 months, or 10 batches manufactured in the last 12 months. |
| 7.2.2.6 | A copy of the validation master plan. |
| 7.2.2.7 | Process validation report for one of the devices intended to be registered in Tanzania. |
| 7.2.2.8 | A copy of the medical devices file for each type and model of the device intended for marketing authorisation. |
| 7.2.2.9 | Report on validation of the sterilisation method (where applicable). |
| 7.2.2.10 | Report on qualification, maintenance and calibration of critical production and quality control equipment relevant to the devices applied for marketing authorisation. |
| 7.2.2.11 | Device master record and a copy of an executed production document of one recent batch of devices applied for registration. |
| 7.2.2.12 | Summary report of internal audits for the last three years. |
| 7.2.2.13 | Risk management framework of the company. |
| 7.2.2.14 | Vendor qualification procedure and reports for critical raw materials used for devices for registration. |
| 7.2.2.15 | Procedures for handling Out-of-Specifications (OOS), including reports of at least three OOS. |
4. What Companies Should Note
Companies that already hold an MDSAP audit report may, when applying for a TMDA medical device quality audit, check whether their manufacturing site meets the conditions for a Desk Review and prepare in advance the ISO 13485 evidence, manufacturing licence, the regulatory audit history of the last three years, the MDSAP audit report and the other quality system documentation required by TMDA.
The continuing expansion of the MDSAP membership also means that a mature quality management system is gaining increasingly broad international recognition.